NB18: Effects Of Ingesting An Energy Bar On Performance And Recovery

Sponsor
Texas A&M University (Other)
Overall Status
Completed
CT.gov ID
NCT03704337
Collaborator
(none)
20
1
2
5.6
3.6

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effects of ingesting a low glycemic whey protein energy bar prior, during and following resistance exercise and conditioning on performance and recovery.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Commercially Available Food Bar
  • Dietary Supplement: Placebo
N/A

Detailed Description

Fit-joy is a commercially available food bar marketed as having a low glycemic index and being relatively high in dietary fiber. The fiber contained within this product is isomalto-oligosaccharides (IMO) which is a food ingredient with a relative sweetness level equal to approximately 60% of sucrose. Chemically, IMO is a mixture of glucose oligomers with alpha - (1-6) - linkages. Short and hard exercise produces muscle damage and soreness. The Fit-joy bar contains whey protein that previous research in the investigator's lab showed may be able to decrease the muscle damaging effects of exercise while also helping with muscle growth. The purpose of this study will be to determine if eating a Fit-joy bar before and in the middle of a hard weight training workout will promote positive results during the workout and 48 hours after the workout.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A randomized, cross-over administration of supplements with approximately 7-10 days between testing sessions.A randomized, cross-over administration of supplements with approximately 7-10 days between testing sessions.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Effects Of Ingesting A Low Glycemic Whey Protein Energy Bar Prior, During And Following Resistance Exercise And Conditioning On Performance And Recovery
Actual Study Start Date :
Dec 13, 2017
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Commercially Available Food Bar

62 g. Food Bar

Dietary Supplement: Commercially Available Food Bar
Active
Other Names:
  • Food Bar
  • Placebo Comparator: Placebo

    25 g. Dextrose

    Dietary Supplement: Placebo
    Placebo
    Other Names:
  • Dextrose Placebo
  • Outcome Measures

    Primary Outcome Measures

    1. Glucose Homeostasis: Glucose [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood glucose (mmol/L) obtained from venous blood draws and analyzed General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's).

    2. Glucose Homeostasis: Insulin [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum insulin (µIU/mL) obtained from venous blood draws and analyzed General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's).

    3. Glucose Homeostasis: Insulin to Glucose Ratio [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes the insulin to glucose ratio obtained from venous blood draws and analyzed General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's).

    4. Exercise Glucose Response [Measured at baseline (0-min); 30-min post ingestion of supplement, midway (60-min) and following (90-min) resistance exercise, following sprint condition exercises (110-min), and following post-exercise assessments (130-min) during each treatment.]

      Changes in arterialized-venous blood glucose (mmol/L) obtained from a dry finger and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's).

    Secondary Outcome Measures

    1. Subjective rating of hypoglycemia [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of hypoglycemia using the following scale: 0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe). Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    2. Subjective rating of dizziness [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of dizziness using the following scale: 0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe). Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    3. Subjective rating of headaches [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of headache using the following scale: 0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe). Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    4. Subjective rating of fatigue [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      A subjective Likert scale that asked participants to rank the frequency and severity of their perceptions of fatigue using the following scale: 0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe). Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    5. Subjective rating of stomach upset [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      A subjective Likert scale that asked participants to rank the frequency and severity of their symptoms of stomach upset using the following scale: 0 (none), 1-4 (light), 5-6 (mild), 7-9 (severe), or 10 (very severe). Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    6. Subjective rating of readiness to perform [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      A subjective Likert scale assessing readiness to perform on a visual analog scale (VAS) measured prior to supplementation, following exercise, and after 48 hours of recovery from exercise. The scale ranges from "1" - strongly disagree they are ready to perform to "5" - they strongly agree they are ready to perform. Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    7. Subjective rating of pain [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      A subjective Likert scale that assessed perceptions of pain in response the application of a standard amount of pressure applied using an algometer and measured prior to supplementation, following exercise, and after 48 hours of recovery from exercise. The scale was a straight horizontal-line with no hash-markings only wording beneath the line, which read from left-to-right "no pain, dull ache, slight pain, more slight pain, painful, very painful, and unbearable pain". Participants were instructed to scribe one clear mark bisecting the line which represented their pain level the best for each of the three pressure application sites. A ruler was used to measure the participant's mark from the left-to-right in cm and was recorded in the data as such numerical value. Data will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    8. Agility Performance Time [Measured 30-min after ingestion of supplement and after performing 60-min of resistance exercise during each treatment.]

      Time in seconds to perform 3 sprints around 4 cones for the Nebraska Agility Drill (NAD) with 30-seconds recovery. The tests were performed after completing the resistance exercise once during each treatment. Individual and cumulative performance times were assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    9. Sprint Performance Times [Measured 30-min after ingestion of supplement and after performing 60-min of resistance exercise during each treatment.]

      Measured as the time (in seconds) it takes to sprint three 40-yard dashes with 30-seconds recovery. The tests were performed after completing the resistance exercise once during each treatment. Individual and cumulative performance times will be assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    10. Maximal voluntary muscle contraction (MVC) leg extension torque [Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.]

      Measured using a Kin-Com isokinetic dynamometer and expressed in Newton meters assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    11. Maximal voluntary muscle contraction (MVC) leg extension force [Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.]

      Measured using a Kin-Com isokinetic dynamometer and expressed in Newtons assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    12. Maximal voluntary muscle contraction (MVC) leg extension power [Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.]

      Measured using a Kin-Com isokinetic dynamometer and expressed in Watts assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    13. Maximal voluntary muscle contraction (MVC) leg extension work [Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.]

      Measured using a Kin-Com isokinetic dynamometer and expressed in Joules assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    14. Maximal voluntary muscle contraction (MVC) leg flexion torque [Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.]

      Measured using a Kin-Com isokinetic dynamometer and expressed in Newton Meters assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    15. Maximal voluntary muscle contraction (MVC) leg flexion force [Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.]

      Measured using a Kin-Com isokinetic dynamometer and expressed in Newtons assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    16. Maximal voluntary muscle contraction (MVC) leg flexion power [Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.]

      Measured using a Kin-Com isokinetic dynamometer and expressed in Watts assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    17. Maximal voluntary muscle contraction (MVC) leg flexion work [Measured prior to supplementation, following 30-min rest and 80-min of exercise, and after 48 hours of recovery from exercise during each treatment.]

      Measured using a Kin-Com isokinetic dynamometer and expressed in Joules assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    18. Markers of Catabolism: Blood Urea Nitrogen [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood urea nitrogen in mmol/L (BUN) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    19. Markers of Catabolism: Creatinine [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood creatinine (umol/L) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    20. Markers of Catabolism: Lactate Dehydrogenase [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood LDH (IUl/L) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    21. Markers of Catabolism: Creatine Kinase [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood CK (IUl/L) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    22. Markers of Catabolism: BUN/Creatinine Ratio [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood BUN/creatinine ratio obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    23. Stress and Sex Hormones: Cortisol [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood cortisol (ug/dL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    24. Stress and Sex Hormones: Testosterone [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood testosterone (ng/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    25. Stress and Sex Hormones: Cortisol to Testosterone Ratio [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in the ratio of cortisol to testosterone obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    26. Markers of Inflammation: Interferon Gama (IFNy) [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood IFNy (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    27. Markers of Inflammation: Interleukin-13 (IL-13) [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood IL-13 (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    28. Markers of Inflammation: Interleukin-1 beta (IL-1ß) [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood IL-1ß (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    29. Markers of Inflammation: Interleukin-4 beta (IL-4) [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood IL-4 (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    30. Markers of Inflammation: Interleukin-6 beta (IL-6) [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood IL-6 (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    31. Markers of Inflammation: Interleukin-8 beta (IL-8) [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood IL-8 (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    32. Markers of Inflammation: Tumor Necrosis Factor alpha (TNFα) [Measured prior to supplementation (Pre), 30-min after ingestion of supplement and after performing the 80-min exercise bout (Post-Exercise), and after 48 hours of recovery from exercise bout (Recovery) during each treatment.]

      Changes in serum blood TNFα (pg/mL) obtained from venous blood draws and assessed via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Participant is between the ages of 18 and 35

    • Participant is apparently healthy

    • Participant is involved in a a consistent strength and conditioning program consisting of upper and lower body resistance exercises as well as cardiovascular or sprint conditioning training (for at least the past year for 2-4 days/week), bench press at least your body weight and squat at least 1.5 times your body weight and/or leg press twice your body weight.

    • Participant has a Body Mass Index (BMI) < 24.9 or Body Fat Percentage (%BF) < 25.0

    Exclusion Criteria:
    • Participant has a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypo-tension, thyroid disease, arrhythmia, cardiovascular disease

    • Participant has a food allergy (i.e., milk, soy, egg, wheat or nuts)

    • Participant uses current prescription medication (birth control is allowed)

    • Participant is pregnant or nursing or plans to become pregnant during the next month

    • Participant has an intolerance to caffeine and/or other natural stimulants

    • Participant has a history of smoking

    • Participant drinks excessively (i.e., 12 drinks per week or more)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Exercise & Sport Nutrition Lab - Human Clinical Research Facility College Station Texas United States 77845

    Sponsors and Collaborators

    • Texas A&M University

    Investigators

    • Principal Investigator: Richard B Kreider, PhD, Texas A&M University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Richard B. Kreider, Executive Director, Human Clinical Research Facility, Texas A&M University
    ClinicalTrials.gov Identifier:
    NCT03704337
    Other Study ID Numbers:
    • IRB2017-0602F
    First Posted:
    Oct 12, 2018
    Last Update Posted:
    Oct 12, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 12, 2018